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Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors
Sponsor: Nuvalent Inc.
Summary
The Expanded Access Program will provide an alternate mechanism for these patients, who lack satisfactory therapeutic alternatives and cannot participate in a zidesamtinib clinical trial, to access investigational zidesamtinib. Following FDA Approval of zidesamtinib on 22 July 2026, the Expanded Access Program is closed in the United States (US); however, it remains open at all non-US sites listed on ClinicalTrials.gov.
Official title: Expanded Access Treatment of Zidesamtinib (NVL-520) in Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
EXPANDED_ACCESS
Enrollment
Not specified
Start Date
Not specified
Completion Date
Not specified
Last Updated
2026-08-25
Healthy Volunteers
Not specified
Interventions
NVL-520
Oral tablet
Locations (30)
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
UZLeuven
Leuven, Belgium
Cross Cancer Institute
Edmonton, Alberta, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, France
GCS IUCT Oncopole
Toulouse, Occitanie, France
CHU de Nantes
Nantes, Pays de la Loire Region, France
Institut Gustave Roussy
Villejuif, Île-de-France Region, France
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy
L'Istituto Europeo di Oncologia S.r.l.
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
IRCCS Istituto Oncologico Veneto
Padova, Italy
AUSL della Romagna - Ravenna
Ravenna, Italy
Istituto Nazionale Tumori "Regina Elena
Roma, Italy
Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Netherlands Cancer Institute: NKI
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
National University Hospital Singapore
Singapore, Singapore
National Cancer Centre Singapore
Singapore, Singapore
Uomi Cancer Center-Clinica Tres Torres
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Gregorio Marañón General University Hospital
Madrid, Spain
Hospital Univ Doce de Octubre
Madrid, Spain
Chung Shan Medical University
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
The Royal Marsden Hospital
Sutton, Surrey, United Kingdom
The Royal Marsden Hospital
London, United Kingdom
The Christie Hospital
Manchester, United Kingdom